"Recovery" from chronic fatigue syndrome after treatments given in the PACE trial.

Editor's Comment: This study made worldwide headlines when it was released on January 31, 2013. It is the most recent in a series of studies designed to prove that CBT and GET are effective treatments for CFS/ME. This study has been roundly criticized for statistical sleight of hand: redefinition of "recovery" (recovery was not measured as a return to work, or as physical improvement, but as "normal" fatigue, a term which encompassed moderate disability), the use of self-reporting as a measurement tool, altering the original protocols to "increase accuracy," failure to account for the 78% who did not "recover," failure to define P (the probability of spontaneous improvement after a year), failure to establish a consistent baseline, and the use of the Oxford Case Definition, which does not exclude depression, to establish the original cohort.

Background: A multi-centre, four-arm trial (the PACE trial) found that rehabilitative cognitive behaviour therapy (CBT) and graded exercise therapy (GET) were more effective treatments for chronic fatigue syndrome (CFS) than specialist medical care (SMC) alone, when each was added to SMC, and more effective than adaptive pacing therapy (APT) when added to SMC. In this study we compared how many participants recovered after each treatment. Method We defined recovery operationally using multiple criteria, and compared the proportions of participants meeting each individual criterion along with two composite criteria, defined as (a) recovery in the context of the trial and (b) clinical recovery from the current episode of the illness, however defined, 52 weeks after randomization. We used logistic regression modelling to compare treatments.

Results: The percentages (number/total) meeting trial criteria for recovery were 22% (32/143) after CBT, 22% (32/143) after GET, 8% (12/149) after APT and 7% (11/150) after SMC. Similar proportions met criteria for clinical recovery. The odds ratio (OR) for trial recovery after CBT was 3.36 [95% confidence interval (CI) 1.64-6.88] and for GET 3.38 (95% CI 1.65-6.93), when compared to APT, and after CBT 3.69 (95% CI 1.77-7.69) and GET 3.71 (95% CI 1.78-7.74), when compared to SMC (p values ?0.001 for all comparisons). There was no significant difference between APT and SMC. Similar proportions recovered in trial subgroups meeting different definitions of the illness.

Conclusions: This study confirms that recovery from CFS is possible, and that CBT and GET are the therapies most likely to lead to recovery.

Having had very severe CFS after Glandular Fever, I am a huge supporter of GET. Having spent two years in bed it was GET that gave me back my life. The CFS/ME community should embrace an essential treatment and not just express their normal knee jerk negative reaction that puts off other CFS patients from committing themselves to a GET program delivered by a trained clinician, and enjoying subsequent benefits.